GET TESTED INTERNATIONAL AB recalls Gonorrhea test
- Recalling company
- GET TESTED INTERNATIONAL AB
- Product
- Gonorrhea test
- Reason
- Distribution without premarket approval/clearance.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Nov 3, 2025
- Reported
- Dec 10, 2025
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 463 units
- Lot / codes
- EAN: 7340221701533; SKU: A-IGO; UDI-DI: None; Lot/Serial Number: All Lots;
- Company location
- Vastervik
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0738-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0738-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.